Oms/Gonvers Retinal Perforator
FDA 510(k) K844448 · Optical Micro Systems, Inc.
510(k) numberK844448
Submission
- Device name
- Oms/Gonvers Retinal Perforator
- Applicant
- Optical Micro Systems, Inc.
Danvers, MA, US - Received
- November 16, 1984
- Decision date
- August 21, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HNM – Needle, Ophthalmic Suturing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K780154 | Needleholder, Microvasular 5 1/2HNM · Traditional | Edward Weck, Inc. | 03/17/1978SE |
More from Edward Weck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K950218 | Oms Slimline Phaco HandpieceHQC · Traditional | 07/17/1995SE |
| K946054 | DiplomaxHQC · Traditional | 07/11/1995SE |
| K935223 | Ophthalmic Surgical SystemHQC · Traditional | 03/14/1994SE |
| K935226 | I/V PoleKYG · Traditional | 02/16/1994SE |
| K935003 | Electric I/V Pole or EIVP2KYG · Traditional | 01/25/1994SE |
| K870068 | Aspiration Reversal Control (Arc) ModuleHQE · Traditional | 02/12/1987SE |
| K844373 | O.M.S. Ultra-PhacoHQC · Traditional | 12/19/1985SE |
| K844895 | Oms Silicone Oil InjectorLWL · Traditional | 06/24/1985SE |
| K844467 | Oms Cryo · Traditional | 02/22/1985SE |
| K844715 | Visc-X Vitreous Aspirating & Cutting Instrument SyHQE · Traditional | 01/22/1985SE |
Questions and answers
When was Oms/Gonvers Retinal Perforator cleared by the FDA?
Oms/Gonvers Retinal Perforator (K844448) received a 510(k) decision of Substantially Equivalent on August 21, 1985, 278 days after the submission was received.
What is the product code of K844448?
The FDA product code is HNM – Needle, Ophthalmic Suturing, a Class I (low risk) device regulated under 21 CFR 886.4350.